Adaptive Stereotactic Body Radiation Therapy to the Prostate and Pelvic Nodes With Simultaneous Integrated Boost to the MR-detected Nodule for Patients With High-risk and Unfavorable Intermediate-risk Prostate Cancer

• Status: Not yet recruiting
• Trial end date: 2029-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

This trial is a prospective clinical trial designed to demonstrate the safety and feasibility of whole-pelvis adaptive prostate stereotactic body radiation therapy (SBRT) with a tumor boost to the magnetic resonance (MR)-detected sites of disease. The hypothesis is that this treatment approach will be safe and feasible with <15% of patients experiencing an acute CTCAEv5 grade ≥3 genitourinary (GU) or gastrointestinal (GI) adverse event.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: Varian Medical Systems
• Treatments: Androgens

Criteria

Inclusion Criteria:

• Pathologically proven adenocarcinoma of the prostate with NCCN high-risk disease or NCCN unfavorable intermediate-risk disease.

• Patients with unfavorable intermediate-risk disease must meet the following criteria:

• At least one intermediate risk factor (IRF):

• PSA 10-20 ng/mL

• cT2b-c (AJCC 8th ed.)

• Gleason score 7

• At least one "unfavorable" intermediate-risk identifier:

• > 1 IRF

• Gleason score 4+3

• ≥ 50% of biopsy cores positive

• NO high-risk features

• Predicted risk of lymph node involvement ≥ 10% using the Memorial Sloan-Kettering prostate cancer nomogram (Appendix A) OR high-risk Decipher score (0.60 - 1.0). For patients with <10% risk of lymph node involvement by the MSKCC nomogram, Decipher testing is required.

• Patients with high-risk disease must meet at least one of the following criteria:

• cT3a-T3b

• PSA > 20

• Gleason score ≥ 8

• 3T MRI scan of the prostate with at least one MR-detectable lesion in the prostate/seminal vesicles (PIRADS 4 or 5) or at least one MR-detectable PIRADS 3 lesion provided there is pathologic correlation from the prostate biopsy.

• Planning to undergo concurrent whole-pelvis SBRT and androgen deprivation therapy (ADT). ADT may be initiated at any time per institutional standard, so long as ADT begins within 60 days of the start of radiotherapy.

• At least 18 years of age.

• ECOG performance status ≤ 1

• Agreement to adhere to Lifestyle Considerations throughout study duration

• Able to complete relevant patient-reported quality-of-life questionnaires in the opinion of the treating physician.

• Able to understand and willing to sign an IRB approved written informed consent document.

Exclusion Criteria:

• Definitive radiologic evidence of nodal (cN+) or metastatic (cM1) disease on conventional imaging (bone scan) or prostate cancer-specific PET/CT scan (NaF PET/CT, Axumin PET/CT, fluciclovine, choline, or PSMA PET/CT scan). Patients with lymph nodes ≥ 1 cm on short axis are ineligible unless the lymph node is read as benign by Radiology.

• Prior androgen deprivation therapy. (If the onset of androgen ablation is ≤ 60 days prior to treatment start, the patient is eligible.) Baseline PSA and testosterone must be obtained prior to start of treatment.

• Systemic chemotherapy within 3 years prior to treatment start.

• Prior radical prostatectomy, pelvic lymph node dissection, prostate cryotherapy, or high-intensity focused ultrasound (HIFU) to the prostate.

• Prior pelvic radiotherapy.

• Presence of baseline CTCAE grade ≥ 2 GI or GU toxicity that does not resolve to grade 1 or less with appropriate intervention.

• cT4 disease.

• American Urologic Association (AUA) urinary symptom score > 15

• Prostate gland measuring >90 cc.

• Unable to get a prostate MRI.

• Unable to get prostate fiducial markers placed for image guided radiation treatment. Rectal hydrogel is optional and is left to the discretion of the treating physician.

• More than 50% of the prostate is involved with cancer on MRI as determined by the treating physician.

• Patients with only PIRADS score of 3 lesions and no MR-fusion biopsy pathologic correlation.

• Hip prosthetic.

• Prior malignancy (except for non-melanoma skin cancer) unless disease-free for at least 2 years. Patients are not eligible if they have had a prior pelvic malignancy (e.g. bladder cancer, rectal cancer).

• Prior transurethral resection of the prostate (TURP) within 3 months prior to registration.

• Uncontrolled intercurrent illness precluding RT and/or ADT including, but not limited to, seizures, myocardial infarction in the past 6 months, current severe or unstable angina pectoris, congestive heart failure requiring hospitalization in the past 6 months, uncontrolled active infection, uncontrolled hypertension, or any condition that in the opinion of the investigator would preclude participation in the study.

• History of inflammatory bowel disease, including ulcerative colitis and Crohn's disease.

• Presence of anal fissure or history of bowel or bladder fistula.

• Scleroderma. Patients who are moderately symptomatic from other autoimmune diseases or patients on biologic therapies for autoimmune diseases are also excluded.

• Known history of HIV or chronic hepatitis B or C. Testing to evaluate for the presence of HIV and/or hepatitis B or C is not required in patients who do not carry the diagnosis.

• Poorly visualized bladder and bowel on diagnostic CT or CT simulation (either due to body habitus or artifact).

• Unable to spend 30 minutes lying on the radiation therapy treatment couch due to significant urinary frequency/urgency or other comorbidities.